Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Access Pharmaceuticals has reported that JCOM Co, its Korean licensee for both MuGard and ProLindac, has received approval from the Korean Food and Drug Administration (KFDA) of its Registration Dossier for MuGard.
Subscribe to our email newsletter
Access Pharmaceuticals said that MuGard is ready-to-use mucoadhesive oral wound rinse and coating for the management of oral mucositis, a debilitating side effect of many anticancer treatments.
As per the agreement, JCOM is responsible for obtaining the necessary regulatory approvals for MuGard in Korea. As soon as JCOM has completed the additional steps required to import MuGard from the US, marketing will commence.
Earlier, MuGard has been launched in the UK, Germany, Italy, Sweden, Norway and Greece through its European partner, SpePharm. Additionally, Access Pharmaceuticals and its respective marketing partners continue preparing for the commercial rollout of MuGard in the US and additional countries in Europe, set for later this year.
Jeffrey Davis, CEO of Access Pharmaceuticals, said: “JCOM is a well-regarded company with an extensive distribution network in Korea. JCOM receiving technical approval is a critical step in the launch of MuGard in Korea and it fits in nicely with our broad commercialization strategy of MuGard in the global market. We look forward to working with them on next steps, including a potential supply arrangement, and to leveraging their expertise throughout the region.”
Yong Seok Kang, CEO of JCOM Co, said: “We are pleased with the continued progress being made to commercialize MuGard in Korea. We remain on track and look forward to commercializing actively in the second half of the year.”